Efficacy and safety of a saquinavir (SQV) based regimen in HIV-1 infected Thai patients who have chronic indinavir (IDV) associated nephrotoxicity.
Primary objective: To determine whether a switch to a SQV can cause improvements in renal function in patients with chronic IDV associated nephrotoxicity without improvement after IDV dose reduction. Secondary objective: 1. To describe the pathophysiology of chronic IDV associated renal impairment through renal biopsies at baseline and week 48 2. To describe the pathophysiology of chronic IDV associated renal impairment through renal tubular function at baseline and week 48 3. To determine whether a switch to an SQV can cause improvements in renal pathophysiology in patients with chronic IDV associated nephrotoxicity through renal biopsies performed at baseline and at weeks 48 4. To determine whether a switch to an SQV results in improvements in hypertension, lipid profiles and cutaneous side effects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SQV/r 1000/100 BID + NNRTI or SQV/r 1600/100 OD + 2 NRTI
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Bangkok, Thailand
Viral load less than 50 copies/ml Improvement of renal functions and renal imaging
Time frame: 48 weeks
Metabolic and cutaneous profile
Time frame: 48 weeks
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